FDA — authorised 23 January 1998
- Application: ANDA072196
- Marketing authorisation holder: GRANATA BIO CORP
- Indication: Labeling
- Status: approved
🇺🇸 CLOMIPHENE in United States
FDA authorised CLOMIPHENE on 23 January 1998
Marketing authorisations
FDA — authorised 30 August 1999
- Application: ANDA075528
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
FDA — authorised 8 November 2024
- Application: ANDA216739
- Marketing authorisation holder: APPCO
- Status: approved
FDA — authorised 12 November 2024
- Application: ANDA216545
- Marketing authorisation holder: RUBICON
- Status: approved
FDA — authorised 3 October 2025
- Application: ANDA219406
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 17 October 2025
- Application: ANDA219781
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
CLOMIPHENE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CLOMIPHENE approved in United States?
Yes. FDA authorised it on 23 January 1998; FDA authorised it on 30 August 1999; FDA authorised it on 8 November 2024.
Who is the marketing authorisation holder for CLOMIPHENE in United States?
GRANATA BIO CORP holds the US marketing authorisation.